LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

• To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  

Drug: Vincristine
1,5 mg/m2 i.v., days 1 and 8
Drug: Daunorubicin
60 mg/m2, i.v., days 1 and 8
Drug: Prednisone
60 mg/m2 day, i.v. or oral, days 1 to 14
Drug: L-Asparaginase
10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.
Drug: Mitoxantrone
12 mg/m2 i.v days 15, 16 and 17
Drug: Cytosine Arabinoside
1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)
Drug: Hydrocortisone
10 mg ,15 mg or 20 mg depending of age
Drug: Mercaptopurine
50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation
Drug: Cyclophosphamide
600 mg/m2 day, i.v., days 1 to 15 in consolidation
Drug: Dexamethasone
10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21

Remission Induction:

• Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
• Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
• Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
• L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13

Results:

1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks

2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C

Intrathecal chemotherapy:

Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT 1

Start in two weeks after last dose of induction chemotherapy:

• Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
• Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
• VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
• ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
• Intrathecal treatment, days 28 and 56.

6.4. CONSOLIDATION TREATMENT 2

Start in a week after last dose of mercaptopurine of previous cycle

• Dexamethasone (DXM):
• 10 mg/m2 day, p.o. or i.v. days 1-14
• 5 mg/m2 day, p.o. or i.v., days 15-21
• Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
• Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
• CFM 600 mg/m2 day, i.v., days 1 and 15
• L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
• Intrathecal treatment days 1 and 15.

TRANSPLANTATION

Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.

Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1

Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching